BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3901875 · Received June 30, 2014

    Report

    Report Number
    9614453-2014-01522
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    May 4, 2014
    Report Date
    June 6, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS IN THE SAME BRAND FAMILY AS A DEVICE MARKETED IN THE U.S. ATTEMPT(S) FOR ADDITIONAL INFORMATION WITH THE PHYSICIAN WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED, IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    A PATIENT WITH AN IMPLANTABLE PULSE GENERATOR (IPG) WAS REPORTED AS DECEASED AND DIED AT HOME AND NO FURTHER INFORMATION IS AVAILABLE. IT WAS ALSO NOTED THAT THE PATIENT WAS A PARTICIPANT IN THE (B)(6) STUDY. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380289 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D354TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death